Starlix mite

Hauptinformation

  • Handelsname:
  • Starlix mite Filmtabletten
  • Darreichungsform:
  • Filmtabletten
  • Zusammensetzung:
  • nateglinidum 60 mg, excipiens pro compresso obducto.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Starlix mite Filmtabletten
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • orales Antidiabetikum

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 55401
  • Berechtigungsdatum:
  • 28-09-2000
  • Letzte Änderung:
  • 24-10-2018

Packungsbeilage

Patienteninformation

Starlix®/Starlix mite

Novartis Pharma Schweiz AG

Was ist Starlix/-mite und wann wird es angewendet?

Starlix/-mite enthält den Wirkstoff Nateglinid, welcher den Blutzuckerspiegel senkt. Starlix/-mite

wird zur Behandlung von Patienten mit Typ 2-Diabetes verordnet, wenn die Krankheit nicht allein

durch Diät und körperliche Betätigung behandelt werden kann. Typ 2-Diabetes wird auch nicht-

insulinabhängiger Diabetes mellitus genannt.

Ihr Arzt bzw. Ihre Ärztin kann Ihnen entweder eine Behandlung mit Starlix/-mite allein oder

zusammen mit einem Präparat mit dem ebenfalls blutzuckersenkenden Wirkstoff Metformin oder

einem Präparat aus der Gruppe der Thiazolidindione (Rosiglitazon, Pioglitazon) verordnen.

Starlix/-mite darf nur auf Verschreibung des Arztes bzw. der Ärztin angewendet werden.

Was sollte dazu beachtet werden?

Die gute Blutzuckereinstellung hängt nicht nur von der medikamentösen Behandlung ab, sondern

entscheidend sind auch die Einhaltung der Diät und ausreichende körperliche Aktivität. Befolgen Sie

deshalb die diesbezüglichen Anweisungen Ihres Arztes bzw. Ihrer Ärztin oder der Diabetesberatung.

Blut- und Urinzuckerspiegel sollten während der Behandlung überwacht und regelmässig kontrolliert

werden.

Wann darf Starlix/-mite nicht angewendet werden?

Wenn Sie auf den Wirkstoff Nateglinid oder einen der Hilfsstoffe überempfindlich reagieren, wenn

Sie an Typ 1-Diabetes (sog. juveniler oder insulinabhängiger Diabetes) leiden, wenn Sie an einem

Diabetes mit Stoffwechselentgleisung (zu hoher Blutzucker und/oder diabetischer Ketoazidose (Ihr

Körper stellt aufgrund eines zu hohen Blutzuckers grosse Mengen einer giftigen Säuren namens

Ketonkörper her)) mit starkem Durst, häufigem Harndrang, Schwäche oder Erschöpfung, Übelkeit,

Kurzatmigkeit oder Verwirrtsein leiden, wenn Sie schwanger sind oder eine Schwangerschaft planen

und wenn Sie stillen, wenn Sie Anzeichen einer Unterzuckerung an sich feststellen wie Schwitzen,

Benommenheit, Zittern, Schwäche, Hunger, Herzklopfen, Müdigkeit oder Übelkeit, dürfen Sie

Starlix/-mite nicht einnehmen und müssen mit Ihrem Arzt oder Ihrer Ärztin sprechen.

Starlix/-mite ist nicht geeignet für Kinder und Jugendliche.

Wann ist bei der Einnahme von Starlix/-mite Vorsicht geboten?

Starlix/-mite kann Unterzuckerung (Hypoglykämie) verursachen. Achten Sie auf Anzeichen wie

Schwitzen, Benommenheit, Zittern, Schwäche, Hunger, Herzklopfen, Müdigkeit oder Übelkeit.

Diese Symptome lassen sich in der Regel rasch durch Einnahme von Zucker (z.B. 2-4 Stück

Würfelzucker, Traubenzucker, süsse Fruchtsäfte oder gezuckerten Tee) beheben. Beachten Sie, dass

künstliche Süssstoffe unwirksam sind.

Ein nicht richtig eingestellter Blutzuckerspiegel kann Ihre Aufmerksamkeit und Reaktionsfähigkeit

vermindern. Sie sollten Vorsichtsmassnahmen ergreifen, um eine Hypoglykämie während des

Lenkens von Fahrzeugen oder beim Bedienen von Maschinen zu vermeiden. Das ist besonders dann

wichtig, wenn bei Ihnen die Anzeichen einer Hypoglykämie nur schwach ausgeprägt sind oder

fehlen oder wenn bei Ihnen häufig Hypoglykämien auftreten. In diesen Fällen sollten Sie in Betracht

ziehen, das Lenken von Fahrzeugen oder das Bedienen von Maschinen zu unterlassen.

Ältere oder schlecht ernährte Patientinnen bzw. Patienten oder Patientinnen bzw. Patienten mit einer

Erkrankung der Nebennieren oder einer schweren Nierenerkrankung reagieren empfindlicher auf

eine Diabetes-Behandlung. Bei diesen Patientinnen bzw. Patienten muss der Blutzucker engmaschig

kontrolliert werden. Durch anstrengende körperliche Betätigung oder Genuss von Alkohol kann das

Risiko für eine Hypoglykämie erhöht sein. In diesen Fällen sollten die Blutzuckerwerte besonders

sorgfältig überwacht werden.

Sprechen Sie mit Ihrem Arzt bzw. mit Ihrer Ärztin, wenn Sie an einer Lebererkrankung leiden.

Gewisse Arzneimittel können die Wirkung von Starlix/-mite verstärken oder abschwächen und damit

zu einer Abnahme oder Erhöhung des Blutzuckerspiegels führen:

·Arzneimittel gegen Entzündungen und Schmerzen, besonders Arzneimittel mit schmerzlindernder,

fiebersenkender und entzündungshemmender Wirkung (z.B. Acetylsalicylsäure),

·Arzneimittel zur Behandlung von Bluthochdruck und Herzkrankheiten (Betablocker und

harntreibende Arzneimittel) oder der Blutfettwerte,

·Arzneimittel zur Behandlung von Hauterkrankungen, Asthma, Allergie und rheumatischen

Erkrankungen. (z.B. Prednison, Cortison),

·Arzneimittel zur Behandlung von Wachstumsstörungen oder bei körperlicher Schwäche (z.B.

Wachstums- oder anabole Hormone) sowie zur Behandlung der Schilddrüse (Schilddrüsenhormone),

·Arzneimittel und Stoffe zur Behandlung von Depressionen (MAO-Hemmer, Johanniskraut) oder

Parkinson-Krankheit,

·Arzneimittel zur Behandlung z.B. von epileptischen Anfällen (Phenytoin),

·Arzneimittel zur Behandlung von Gicht, Tuberkulose oder Pilzinfektionen,

·Guanethidin,

·Somatostatin-Analoga z.B. Lanreotid, Octreotid, die zur Behandlung von Patienten mit

Akromegalie angewendet werden

·Alkohol.

Teilen Sie Ihrem Arzt bzw. Ihrer Ärztin mit, wenn Sie eines der genannten Arzneimittel einnehmen.

Teilen Sie Ihrem Arzt bzw. Ihrer Ärztin auch mit, wenn Sie an Fieber, Verletzungen, oder an

Infektionen leiden oder operiert werden müssen. Er bzw. sie wird je nach Fall eine Dosisanpassung

vornehmen und den Blutzuckerspiegel genauer überwachen.

Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie

·an anderen Krankheiten leiden,

·Allergien haben oder

·andere Arzneimittel (auch selbstgekaufte!) einnehmen oder äusserlich anwenden.

Darf Starlix/-mite während einer Schwangerschaft oder in der Stillzeit eingenommen werden?

Starlix/-mite darf weder in der Schwangerschaft noch in der Stillzeit eingenommen werden.

Informieren Sie Ihren Arzt bzw. Ihre Ärztin, wenn Sie feststellen, dass Sie schwanger sind. Während

der Behandlung mit Starlix/-mite sollten Frauen im gebärfähigen Alter eine zuverlässige

Verhütungsmethode anwenden.

Wie verwenden Sie Starlix/-mite?

Die übliche tägliche Dosierung beträgt je 1 Filmtablette Starlix à 120 mg vor den Hauptmahlzeiten,

gewöhnlich vor dem Morgen-, Mittag- und Abendessen. Bei Patientinnen bzw. Patienten mit

schweren Nierenerkrankungen beträgt die übliche tägliche Dosierung 1 Filmtablette Starlix mite à

60 mg vor den Hauptmahlzeiten. Die Filmtabletten sollen unzerkaut unmittelbar vor dem Essen mit

einem Glas Wasser eingenommen werden. Sie können die Filmtabletten auch zu irgendeinem

Zeitpunkt innerhalb von 30 min vor dem Essen einnehmen.

·Wenn Sie eine Mahlzeit auslassen, verzichten Sie auf die entsprechende Einnahme von Starlix /-

mite.

·Wenn Sie einmal vergessen haben, eine Filmtablette einzunehmen, nehmen Sie die nächste Dosis

erst wieder vor der nächsten Mahlzeit. Verdoppeln Sie die Dosis nicht.

·Starlix/-mite kann von Ihrem Arzt bzw. Ihrer Ärztin zusammen mit anderen oralen

blutzuckersenkenden Arzneimitteln verordnet werden. Eventuell wird der Arzt bzw. die Ärztin dann

die Dosis von Starlix/-mite anpassen.

·Ändern Sie nicht von sich aus die verschriebene Dosierung. Wenn Sie glauben, das Arzneimittel

wirke zu schwach oder zu stark, so sprechen Sie mit Ihrem Arzt oder Apotheker bzw. mit Ihrer

Ärztin oder Apothekerin.

Welche Nebenwirkungen kann Starlix/-mite haben?

Folgende Nebenwirkungen können bei der Einnahme von Starlix/-mite auftreten:

Starlix/-mite kann häufig eine Unterzuckerung (Hypoglykämie) mit den folgenden Symptomen

bewirken:

Schwitzen, Benommenheit, Zittern, Schwächegefühl, Hunger, Herzklopfen, Müdigkeit oder

Übelkeit. Zur Behebung dieser Symptome siehe unter «Wann ist bei der Einnahme von Starlix/-mite

Vorsicht geboten?».

Häufig kann es auch zu Bauchschmerzen, Völlegefühl, Blähungen, Übelkeit und Durchfall,

gelegentlich auch zu Erbrechen kommen.

In Einzelfällen können auch Überempfindlichkeitsreaktionen wie Ausschlag und Juckreiz sowie

Erhöhung der Leberwerte auftreten. Falls diese Symptome bei Ihnen auftreten, sollten Sie sich an

Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin wenden.

Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder

Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.

Was ist ferner zu beachten?

Starlix/-mite soll nicht über 30 °C im Originalbehälter und für Kinder unerreichbar aufbewahrt

werden.

Das Arzneimittel darf nur bis zu dem auf dem Behälter mit «EXP» bezeichneten Datum verwendet

werden.

Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese

Personen verfügen über die ausführliche Fachinformation.

Was ist in Starlix/-mite enthalten?

Starlix/-mite enthält den Wirkstoff Nateglinid und Hilfsstoffe. Es gibt Filmtabletten zu 60 mg

(pinkfarben und rund) und zu 120 mg (gelb und oval).

Zulassungsnummer

55401 (Swissmedic).

Wo erhalten Sie Starlix/-mite? Welche Packungen sind erhältlich?

In Apotheken nur gegen ärztliche Verschreibung.

Starlix mite Filmtabletten zu 60 mg: 84.

Starlix Filmtabletten zu 120 mg: 84.

Zulassungsinhaberin

Novartis Pharma Schweiz AG, Risch; Domizil: 6343 Rotkreuz.

Diese Packungsbeilage wurde im Juli 2015 letztmals durch die Arzneimittelbehörde (Swissmedic)

geprüft.

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EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

22-10-2018

EU/3/17/1966 (Sirius Regulatory Consulting EU Limited)

EU/3/17/1966 (Sirius Regulatory Consulting EU Limited)

EU/3/17/1966 (Active substance: N-(bromoacetyl)-3,3-dinitroazetidine) - Transfer of orphan designation - Commission Decision (2018)6986 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

16-10-2018

Dexxience (Portola Pharma UK Limited)

Dexxience (Portola Pharma UK Limited)

Dexxience (Active substance: betrixaban) - Refusal of authorisation - Commission Decision (2018)6226 of Tue, 16 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4309

Europe -DG Health and Food Safety

2-10-2018

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)6458 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/IB/14

Europe -DG Health and Food Safety

2-10-2018

Intuniv (Shire Pharmaceuticals Ireland Limited)

Intuniv (Shire Pharmaceuticals Ireland Limited)

Intuniv (Active substance: guanfacine) - Centralised - Yearly update - Commission Decision (2018)6473 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Vimizim (BioMarin International Limited)

Vimizim (BioMarin International Limited)

Vimizim (Active substance: elosulfase alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6491 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002779/T/0026

Europe -DG Health and Food Safety

25-9-2018

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (Active substance: melatonin) - Centralised - Authorisation - Commission Decision (2018)6223 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

24-9-2018

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (Active substance: nitisinone) - Centralised - Yearly update - Commission Decision (2018)6241 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Active substance: Eravacycline) - Centralised - Authorisation - Commission Decision (2018)6231 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4237

Europe -DG Health and Food Safety

24-9-2018

Cosentyx (Novartis Europharm Limited)

Cosentyx (Novartis Europharm Limited)

Cosentyx (Active substance: secukinumab) - PSUSA - Modification - Commission Decision (2018)6213 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010341/201712

Europe -DG Health and Food Safety

24-9-2018

Mitem® 20 mg

Rote - Liste

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

Spinraza (Biogen Idec Limited)

Spinraza (Biogen Idec Limited)

Spinraza (Active substance: nusinersen) - Centralised - 2-Monthly update - Commission Decision (2018)5862 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/II/4

Europe -DG Health and Food Safety

29-8-2018

Mekinist (Novartis Europharm Limited)

Mekinist (Novartis Europharm Limited)

Mekinist (Active substance: trametinib) - Centralised - 2-Monthly update - Commission Decision (2018)5778 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2643/WS/1274

Europe -DG Health and Food Safety

29-8-2018

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (Active substance: mepolizumab) - Centralised - 2-Monthly update - Commission Decision (2018)5770 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3860/II/13/G

Europe -DG Health and Food Safety

29-8-2018

Varuby (TESARO U.K. Limited)

Varuby (TESARO U.K. Limited)

Varuby (Active substance: rolapitant) - Centralised - Yearly update - Commission Decision (2018)5765 of Wed, 29 Aug 2018

Europe -DG Health and Food Safety

28-8-2018

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

Kalydeco (Active substance: ivacaftor) - PASS - Modification - Commission Decision (2018)5693 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2494/RSR/S/14

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2062 (IQVIA RDS Ireland Limited)

EU/3/18/2062 (IQVIA RDS Ireland Limited)

EU/3/18/2062 (Active substance: Bertilimumab) - Orphan designation - Commission Decision (2018)5740 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2060 (Biogen Idec Limited)

EU/3/18/2060 (Biogen Idec Limited)

EU/3/18/2060 (Active substance: Adeno-associated viral vector serotype hu68 containing the human SMN1 gene) - Orphan designation - Commission Decision (2018)5732 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (Active substance: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate) - Orphan designation - Commission Decision (2018)5730 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/099/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2063 (IQVIA RDS Ireland Limited)

EU/3/18/2063 (IQVIA RDS Ireland Limited)

EU/3/18/2063 (Active substance: CD34+ haematopoietic stem and progenitor cells with CD3+ T-cells) - Orphan designation - Commission Decision (2018)5733 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/088/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (Active substance: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate) - Orphan designation - Commission Decision (2018)5727 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/060/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Active substance: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2) - Orphan designation - Commission Decision (2018)5737 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/044/18

Europe -DG Health and Food Safety

28-8-2018

Orkambi (Vertex Pharmaceuticals (Europe) Limited)

Orkambi (Vertex Pharmaceuticals (Europe) Limited)

Orkambi (Active substance: Lumacaftor/Ivacaftor) - PSUSA - Modification - Commission Decision (2018)5710 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10455/201711

Europe -DG Health and Food Safety

27-8-2018

Firazyr (Shire Pharmaceuticals Ireland Limited)

Firazyr (Shire Pharmaceuticals Ireland Limited)

Firazyr (Active substance: icatibant) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5697 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/899T/41

Europe -DG Health and Food Safety

27-8-2018

Kymriah (Novartis Europharm Limited)

Kymriah (Novartis Europharm Limited)

Kymriah (Active substance: tisagenlecleucel) - Centralised - Authorisation - Commission Decision (2018)5717 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4090

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

25-8-2018

Xagrid (Shire Pharmaceuticals Ireland Limited)

Xagrid (Shire Pharmaceuticals Ireland Limited)

Xagrid (Active substance: anagrelide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5682 of Sat, 25 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/480/T/82

Europe -DG Health and Food Safety